a study to evaluate the tolerance, pharmacokinetics and efficacy of tq-a3334 tablets

Conditions: Non-small Cell Lung Cancer

Summary: this is a study to evaluate the tolerance, dose-limiting toxicity (dlt), and maximum tolerated dose (mtd) of single and multiple oral doses of tq-a3334 and observe the efficacy of tq-a3334 in combination with anlotinib capsules in patients with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * 1.understood and signed an informed consent form; 2. 18 years old and older; eastern cooperative oncology group (ecog) performance status score of 0 to 1; life expectancy ≥12 weeks; 3.histologically confirmed advanced non-small cell lung cancer; 4. has received at least two systemic chemotherapy regimens which is failure or intolerance; 5. at least one measurable lesion（ based on recist1.1）; 6. the main organs function are normally; 7. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization; 8. in addition to the above criteria, the extended research phase must meet the following criteria: egfr and alk are negative; or patients with positive test results of egfr and alk are resistant or intolerant after receiving the targeted drug treatment. exclusion criteria: * 1. small cell lung cancer; 2. other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer; 3. has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin c and nitrosourea for less than 6 weeks; 4. expect to use any active vaccine against infectious diseases within 28 days before the first administration or during the study period; 5. immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage \> 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration; 6. active autoimmune diseases that require systemic treatment have occurred within 2 years before the first administration; 7. hypersensitivity to tqb3804 or its excipient; 8. has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis; 9. has unrelieved toxicity reactions ≥ grade 1 due to previous treatment; 10. imaging (ct or mri) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear; 11. has thyroid dysfunction that requires drug treatment within 6 months before the first administration; 12. has multiple factors affecting oral medication; 13.has any severe acute complications before the first administration; 14. have participated in other clinical trials within 4 weeks before the first administration; 15. according to the judgement of the researchers, there are other factors that may lead to the termination of the study; 16. in addition to the above criteria, the extended research phase must meet the following criteria: 1) pathologically diagnosed as central, hollow lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis ; 2) egfr and alk are positive untreated with relevant targeted drugs; 3) has received anlotinib hydrochloride capsules.